Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II. Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01707745
• Other study ID #: Avastin for threshold ROP.
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2012
• Last updated: October 15, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Dubai Health Authority
• Contact: Sivakami A Pai, MS, DNB, Phd
• Phone: 00971504148256
• Is FDA regulated: No
• Health authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 42 Weeks

Eligibility

Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

Exclusion Criteria:

Refusal to give consent Critically ill neonates.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinopathy of Prematurity
• Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.

Intervention

Procedure:
• Intravitreal Bevacizumab

Locations

Country	Name	City	State
United Arab Emirates	Dubai Hospital	Dubai	UAE

Sponsors (1)

Lead Sponsor	Collaborator
Sivakami A Pai

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression Of ROP		Minimum 6 months follow up after intravitreal Avastin	Yes
Secondary	Recurrence of ROP		minimum 6 months of follow up.	Yes